3D-printed drug approved by US FDA

By Edd Gent

Published Tuesday, August 4, 2015

A 3D-printed drug has been approved for the first time by the US Food and Drug Administration.

Spritram, made by Aprecia Pharmaceuticals, was approved for oral use as an adjunctive therapy - a medicine the patient takes in addition to their primary medication to improve its effectiveness - for the treatment of epilepsy. The active ingredient is the anti-convulsant levetiracetam.

The drug uses Aprecia's proprietary "ZipDose" technology, which uses 3D printing to create a delivery system that delivers premeasured doses which disintegrate in the mouth with a sip of liquid much faster than traditional solutions.

“By combining 3DP technology with a highly prescribed epilepsy treatment, Spritram is designed to fill a need for patients who struggle with their current medication,” said Don Wetherhold, CEO of Aprecia. “This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication.”

The company's technology builds on powder-liquid 3D-printing techniques first developed at the Massachusetts Institute of Technology (MIT).

Thin layers of powdered medication are spread on top of one another and at each level liquid droplets are deposited onto selected regions of each powder layer in a specific pattern that helps bond the materials together, while still maintaining a highly porous structure.

This porous structure makes it easy for liquid to penetrate the delivery system and rapidly disintegrate the bonds created during printing, meaning the medication dissolves much faster than traditional solutions even at high doses. Accordingly, even the largest doses of levetiracetam can be administered in one go.

3D printing has already been used in the healthcare industry by dentists to create replicas of jaws and teeth as well as some finished dental implants, while orthopaedic surgeons have tested them to make customised hip replacements.

Expansion of the highly customisable technology could also allow companies make products "to the specifications of an individual patient rather than [take a] one-size-fits-all kind of approach," Wedbush Securities analyst Tao Levy said.